Investigation of PicoPrep Versus HalfLytely for Bowel Preparation for Colonoscopy - Day Before PicoPrep

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Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

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Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

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Reporting Groups

Description

PicoPrep

"Day Before" method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy

HalfLytely

HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.

Participant Flow: Overall Study

PicoPrep

HalfLytely

STARTED

300

303

Safety Population (Treated)

296

302

Intent to Treat Population

294 [1]

300 [1]

COMPLETED

287

295

NOT COMPLETED

13

8

Withdrawal by Subject

8

2

Protocol Violation

2

1

Adverse Event

1

1

Lost to Follow-up

0

2

Power outage; colonoscopy not done

1

0

Subject forgot

0

1

Unable to return for follow-up

0

1

Could not tolerate prep

1

0

[1]

Two treated participants did not have an efficacy assessment performed.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

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Reporting Groups

Description

PicoPrep

"Day Before" method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy

HalfLytely

HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.

Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Ascending Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist [ Time Frame: Day 2 ]

Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Ask Your Doctor for This Preparation Again if You Need Another Colonoscopy in the Future? [ Time Frame: Day 2 ]

Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Refuse the Same Preparation Again if it Were to be Prescribed to You in the Future? [ Time Frame: Day 2 ]

Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist [ Time Frame: Day 2 ]